A longitudinal program for biomarker development in Parkinson's disease: a feasibility study.
Identifieur interne : 001B93 ( PubMed/Curation ); précédent : 001B92; suivant : 001B94A longitudinal program for biomarker development in Parkinson's disease: a feasibility study.
Auteurs : Bernard Ravina [États-Unis] ; Caroline Tanner ; Diane Dieuliis ; Shirley Eberly ; Emily Flagg ; Wendy R. Galpern ; Stanley Fahn ; Christopher G. Goetz ; Stephen Grate ; Roger Kurlan ; Anthony E. Lang ; Kenneth Marek ; Karl Kieburtz ; David Oakes ; Robin Elliott ; Ira ShoulsonSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2009.
English descriptors
- KwdEn :
- MESH :
- chemical , genetics : DNA.
- chemical : Biological Markers.
- diagnosis : Parkinson Disease.
- physiology : Movement.
- Aged, Clinical Trials as Topic, Cohort Studies, Data Interpretation, Statistical, Feasibility Studies, Female, Follow-Up Studies, Humans, Longitudinal Studies, Male, Middle Aged, Patient Selection.
Abstract
Long-term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS-PD) is an observational study designed to prospectively measure the evolution of motor and non-motor features of PD and sample promising biomarkers from early to late stage illness. LABS-PD is organized on the premise that cohorts from completed clinical trials can be re-recruited for long-term follow up. LABS-PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow-up. A biomarker sub-study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, alpha-synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS-PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data.
DOI: 10.1002/mds.22690
PubMed: 19691116
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Galpern</name></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name></author><author><name sortKey="Goetz, Christopher G" sort="Goetz, Christopher G" uniqKey="Goetz C" first="Christopher G" last="Goetz">Christopher G. Goetz</name></author><author><name sortKey="Grate, Stephen" sort="Grate, Stephen" uniqKey="Grate S" first="Stephen" last="Grate">Stephen Grate</name></author><author><name sortKey="Kurlan, Roger" sort="Kurlan, Roger" uniqKey="Kurlan R" first="Roger" last="Kurlan">Roger Kurlan</name></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E" last="Lang">Anthony E. Lang</name></author><author><name sortKey="Marek, Kenneth" sort="Marek, Kenneth" uniqKey="Marek K" first="Kenneth" last="Marek">Kenneth Marek</name></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name></author><author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name></author><author><name sortKey="Elliott, Robin" sort="Elliott, Robin" uniqKey="Elliott R" first="Robin" last="Elliott">Robin Elliott</name></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Biological Markers</term><term>Clinical Trials as Topic</term><term>Cohort Studies</term><term>DNA (genetics)</term><term>Data Interpretation, Statistical</term><term>Feasibility Studies</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Movement (physiology)</term><term>Parkinson Disease (diagnosis)</term><term>Patient Selection</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>DNA</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Biological Markers</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Movement</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Clinical Trials as Topic</term><term>Cohort Studies</term><term>Data Interpretation, Statistical</term><term>Feasibility Studies</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Patient Selection</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Long-term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS-PD) is an observational study designed to prospectively measure the evolution of motor and non-motor features of PD and sample promising biomarkers from early to late stage illness. LABS-PD is organized on the premise that cohorts from completed clinical trials can be re-recruited for long-term follow up. LABS-PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow-up. A biomarker sub-study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, alpha-synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS-PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">19691116</PMID><DateCreated><Year>2009</Year><Month>11</Month><Day>05</Day></DateCreated><DateCompleted><Year>2010</Year><Month>01</Month><Day>12</Day></DateCompleted><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>24</Volume><Issue>14</Issue><PubDate><Year>2009</Year><Month>Oct</Month><Day>30</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>A longitudinal program for biomarker development in Parkinson's disease: a feasibility study.</ArticleTitle><Pagination><MedlinePgn>2081-90</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.22690</ELocationID><Abstract><AbstractText>Long-term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS-PD) is an observational study designed to prospectively measure the evolution of motor and non-motor features of PD and sample promising biomarkers from early to late stage illness. LABS-PD is organized on the premise that cohorts from completed clinical trials can be re-recruited for long-term follow up. LABS-PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow-up. A biomarker sub-study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, alpha-synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS-PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data.</AbstractText><CopyrightInformation>(c) 2009 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ravina</LastName><ForeName>Bernard</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. bernard.ravina@ctcc.rochester.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tanner</LastName><ForeName>Caroline</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Dieuliis</LastName><ForeName>Diane</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Eberly</LastName><ForeName>Shirley</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Flagg</LastName><ForeName>Emily</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Galpern</LastName><ForeName>Wendy R</ForeName><Initials>WR</Initials></Author><Author ValidYN="Y"><LastName>Fahn</LastName><ForeName>Stanley</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Goetz</LastName><ForeName>Christopher G</ForeName><Initials>CG</Initials></Author><Author ValidYN="Y"><LastName>Grate</LastName><ForeName>Stephen</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Kurlan</LastName><ForeName>Roger</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Lang</LastName><ForeName>Anthony E</ForeName><Initials>AE</Initials></Author><Author ValidYN="Y"><LastName>Marek</LastName><ForeName>Kenneth</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Kieburtz</LastName><ForeName>Karl</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Oakes</LastName><ForeName>David</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Elliott</LastName><ForeName>Robin</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Shoulson</LastName><ForeName>Ira</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><CollectiveName>Parkinson Study Group LABS-PD Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>5U01NS050095-05</GrantID><Acronym>NS</Acronym><Agency>NINDS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015415">Biological Markers</NameOfSubstance></Chemical><Chemical><RegistryNumber>9007-49-2</RegistryNumber><NameOfSubstance UI="D004247">DNA</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D015415">Biological Markers</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002986">Clinical Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015331">Cohort Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004247">DNA</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000235">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D003627">Data Interpretation, Statistical</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005240">Feasibility Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008137">Longitudinal Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009068">Movement</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000502">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000175">diagnosis</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018579">Patient Selection</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Shoulson</LastName><ForeName>Ira</ForeName><Initials>I</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kieburtz</LastName><ForeName>Karl</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ravina</LastName><ForeName>Bernard</ForeName><Initials>B</Initials></Investigator><Investigator ValidYN="Y"><LastName>Oakes</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Flagg</LastName><ForeName>Emily</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kurlan</LastName><ForeName>Roger</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lang</LastName><ForeName>Anthony</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Goetz</LastName><ForeName>Christopher</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Marek</LastName><ForeName>Kenneth</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Tanner</LastName><ForeName>Caroline</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Elliot</LastName><ForeName>Robin</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Fahn</LastName><ForeName>Stanley</ForeName><Initials>S</Initials></Investigator><Investigator 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